Safety and Tolerability of TASIS-Peanut (Targeted Allergen Specific Immunotherapy within the Skin) patch for the Treatment of Peanut Allergy

以下包含Moonlight Treateutics要求不向政府以外的人发布的专有/特权信息，但出于以下目的 评审和评估 TASIS-花生(靶向变态反应原特异性免疫疗法)的安全性和耐受性 皮肤)贴片治疗花生过敏 食物过敏影响着美国的3000万人和欧洲的1700万人。美国有600万儿童，大约每13人中就有1人 至少有一种食物过敏；这相当于每个教室至少有一种食物过敏。目前，只有一家FDA批准了 美国的食物过敏疗法。食物过敏预计将以每年10%的速度增长，至少到2022年。它也是 一个人有不止一种过敏症是很常见的。这是一个增长中的、服务不足的全球市场，几乎没有什么待遇。 选择。一种有意义的初步治疗将是减少意外后发生过敏反应的机会 曝光。这样的疗法将有助于给家庭带来安心，允许受食物过敏影响的儿童 提高生活质量，减少被社会排斥的感觉，最重要的是减少意外死亡的可能性 程序。 月光疗法公司正在开发一种有针对性的方法，将变应原注射到皮肤表层，以使皮肤脱敏 过敏性患者，称为皮肤靶向过敏原特异性免疫疗法(TASIS)。交付通过以下方式实现 微针贴在皮肤上几分钟，这是微创和无痛的。重要的是微针 能以极高的精确度和重复性输送到最上层的皮肤。因为TASIS在顶端提供小剂量 对于皮肤和浅层，这种方法预计几乎不会产生全身不良反应。该公司的 第一种疗法是针对花生过敏的，被称为TASIS-花生。我们已经证明了我们方法的有效性 花生致敏的临床前小鼠模型。 这种快速通道(阶段1/阶段2)SBIR赠款(U44)申请是为了进行阶段1安全和耐受性研究 由该公司和合作的临床研究网站合作进行。U44 Fast的目标是- 跟踪资助是准备(资助阶段1)和进行(资助阶段2)一期临床试验的文件，以 评估TASIS-花生在花生过敏儿童和成人中的安全性和耐受性。赠款的第二阶段部分 还包括旨在为临床试验生产TASIS-花生的目标。该公司目前拥有一款R42 为TASIS-花生的临床前开发提供快速通道赠款。 总体而言，这笔赠款将使TASIS-花生的安全性和耐受性能够在第一次人类临床试验中得到评估。会的 为第二阶段临床试验的疗效评估奠定基础。

The following contains proprietary/privileged information that Moonlight Therapeutics requests not be released to persons outside the government, except for purposes of review and evaluation Safety and Tolerability of TASIS-Peanut (Targeted Allergen Specific Immunotherapy within the Skin) patch for the Treatment of Peanut Allergy Food allergies affect 30 million people in the USA and 17 million in Europe. Six million children, roughly 1 in 13, in the USA have at least one food allergy; this equates to at least 1 in every classroom. Currently, there is only one FDA approved therapy in the USA for food allergies. Food allergies are expected to grow 10% annually until at least 2022. It is also common for someone to have more than one allergy. This is a growing, underserved global market that has few treatment options. A meaningful initial therapy would be one that reduces the chance for anaphylactic reaction after accidental exposure. Such a therapy will help bring peace of mind to families, allow for children affected by food allergies to have better quality of life, feel less socially out casted and most importantly reduce the potential for death from accidental procedure. Moonlight Therapeutics is developing a targeted way to administer allergens into the top skin layers to desensitize an allergic patient, called Targeted Allergen Specific Immunotherapy in the Skin (TASIS). Delivery is achieved using microneedles applied to the skin for a few minutes, which are minimally invasive and painless. Importantly microneedles can deliver into topmost skin layers with high precision and reproducibility. Because TASIS delivers small doses in the top and superficial skin layers, the approach is expected to produce little to no systemic adverse reactions. The company's first treatment is focused on peanut allergy and is called TASIS-Peanut. We have demonstrated efficacy of our approach in a pre-clinical mouse model of peanut sensitization. This Fast-track (Phase1/Phase2) SBIR grant (U44) application is for a Phase 1 safety and tolerability study to be conducted in partnership between the company and collaborating clinical research sites. The objective of the U44 Fast- track grant is to prepare documents for (grant PHASE 1) and conduct (grant PHASE 2) a Phase 1 clinical trial to assess the safety and tolerability of TASIS-Peanut in peanut allergic children and adults. The Phase 2 portion of the grant also includes aims geared towards production of TASIS-Peanut for the clinical trial. The company currently has a R42 Fast-track grant for the pre-clinical development of TASIS-Peanut. Overall this grant will enable evaluation of the safety and tolerability of TASIS-Peanut in a first-in-human clinical trial. It will set the stage for evaluation of efficacy in a Phase 2 clinical trial.